Self-Control in Bulimia Nervosa

NCT04409457 | Completed Results DMC

• 2 other identifiers: GCO 19-1047K23MH118418
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study examines the influence of acute fasting and eating on self-control in adult females with and without bulimia nervosa (BN). Specifically, the study team is investigating whether differences in behavior and brain activation in response to computer tasks after fasting and after eating a meal could help to explain the symptoms of bulimia nervosa. Data will be collected using questionnaires and a technology called magnetic resonance imaging (MRI).

Conditions

Bulimia Nervosa

Keywords

bulimia nervosa; binge eating; purging; fasting; eating disorder; control

Outcome Measures

Primary Outcomes (4)

• Brain Activation Associated With P(Stop)

  Frontostriatal activation modulated by the predicted need for inhibition (P(stop) (i.e., parametric modulation by p(Stop)), measured as the mean BOLD signal across voxels within the region of interest (ROI). Positive values indicate that neural activation increases as the predicted probability of needing to stop increases (i.e., stronger responses when stopping is predicted to be more likely), whereas negative values indicate that activation decreases as the predicted probability of needing to stop increases (i.e., greater activation when stopping is predicted to be less likely).

  after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart)

• Brain Activation Associated With Prediction Errors (Unsigned)

  Frontostriatal activation modulated by unsigned inhibitory control prediction errors (i.e., parametric modulation by absolute prediction error magnitude), measured as the mean BOLD signal across voxels within the region of interest (ROI). Positive values indicate that neural activation increases with the magnitude of unsigned prediction errors (i.e., stronger responses to more surprising outcomes), whereas negative values indicate that activation decreases as unsigned prediction errors increase (i.e., relative deactivation for more surprising outcomes).

  after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart)

• Brain Activation Associated With Prediction Errors (Signed)

  Frontostriatal activation modulated by signed inhibitory control prediction errors (i.e., parametric modulation by prediction error magnitude), measured as the mean BOLD signal across voxels within the region of interest (ROI). Positive values indicate that neural activation increases as signed prediction errors become more positive (i.e., stronger responses to the surprising need for control), whereas negative values indicate that activation decreases as signed prediction errors become more positive (i.e., stronger responses to the surprising lack of need for control).

  after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart)

• Brain Activation Associated With Successful Inhibition

  Frontostriatal activation associated with successful inhibition , measured as the mean BOLD signal across voxels within the region of interest (ROI) for the contrast of Successful Stop vs. Go trials. Positive values indicate activation associated with successful inhibition.

  after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart)

Secondary Outcomes (2)

• Stop Signal Reaction Time (SSRT)

  after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart)

• Stop Signal Task Inhibition

  after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart)

Study Arms (2)

Participants with Bulimia Nervosa

OTHER

Participants are randomly assigned (in even numbers across the two groups) to scan order: A. These participants are first scanned after 16 hours of fasting on one day, and are next scanned after a standardized meal on a second day. B. These participants are first scanned after a standardized meal on one day, and are next scanned after 16 hours of fasting on a second day.

Other: fasting state; Other: fed state; Other: magnetic resonance imaging

Participants without Bulimia Nervosa

OTHER

Participants are randomly assigned (in even numbers across the two groups) to scan order: A. These participants are first scanned after 16 hours of fasting on one day, and are next scanned after a standardized meal on a second day. B. These participants are first scanned after a standardized meal on one day, and are next scanned after 16 hours of fasting on a second day.

Other: fasting state; Other: fed state; Other: magnetic resonance imaging

Interventions

fasting state OTHER

16 hours of fasting

Participants with Bulimia Nervosa; Participants without Bulimia Nervosa

fed state OTHER

fed a standardized meal

Participants with Bulimia Nervosa; Participants without Bulimia Nervosa

magnetic resonance imaging OTHER

neuroimaging with computational modeling

Also known as: MRI

Participants with Bulimia Nervosa; Participants without Bulimia Nervosa

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: The prevalence of bulimia nervosa is substantially greater in women than in men. Moreover, prior research suggest that men and women show different neural response patterns during the engagement of inhibitory control, and that satiety differentially impacts the neural function of men and women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female
• Aged 18 to 35 years
• Currently between 85 and 130% of the expected weight for height
• Right-handed
• English-speaking
• \- Meet DSM-5 criteria for bulimia nervosa

You may not qualify if:

• Medical instability
• Ongoing medical treatment, medical condition, or psychiatric disorder that may interfere with study variables or participation
• Shift work
• Pregnancy, planned pregnancy, or lactation during the study period
• Allergy to any of the ingredients in or unwillingness to consume the standardized meal or unwillingness to drink water during the fasting period
• Any contraindication for fMRI

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Bulimia Nervosa; Bulimia; Fasting; Feeding and Eating Disorders

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Mental Disorders; Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Laura Berner
• Organization: Icahn School of Medicine at Mount Sinai

laura.berner@mssm.edu

332-243-7259

Study Officials

• Laura A Berner, PhD

  Department of Psychiatry, Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Model Details: Two participant groups (one with and one without bulimia nervosa) will be scanned using MRI after they have fasted and after they have consumed a standardized meal. The order of these two scans will be counterbalanced across groups.

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: June 1, 2020
• Study Start: September 18, 2020
• Primary Completion: November 5, 2024
• Study Completion: November 5, 2024
• Last Updated: February 6, 2026
• Results First Posted: January 14, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Beginning 24 months following peer-reviewed article publication
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.

Locations

US (1)